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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K192011

PhoeniX · Sedecal., Sa. · decided 2019-09-25 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
SEDECALODYSSEYSEDECALIZL MQB08436046003682
SEDECALODYSSEY+SEDECALIZL MQB08436046003705
SEDECALODYSSEYSEDECALIZL MQB08436046003651
SEDECALPhoeniXSEDECALIZL MQB08436046002364
SEDECALODYSSEYSEDECALIZL MQB08436046003668
SEDECALODYSSEY+SEDECALIZL MQB08436046003699
SEDECALODYSSEY+SEDECALIZL MQB08436046003729
SEDECALPhoeniXSEDECALIZL MQB08436046002470
SEDECALPhoeniXSEDECALIZL MQB08436046002487
SEDECALODYSSEY+SEDECALIZL MQB08436046003712
SEDECALODYSSEYSEDECALIZL MQB08436046003675
SEDECALPhoeniXSEDECALIZL MQB08436046002494